1
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: not found

      Efficacy and safety of loxoprofen sodium topical patch for the treatment of pain in patients with minor acute traumatic limb injuries in Brazil: a randomized, double-blind, noninferiority trial.

      Read this article at

      ScienceOpenPublisherPubMed
      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          Posttraumatic injury pain is commonly treated with oral nonsteroidal anti-inflammatory drugs. However, oral nonsteroidal anti-inflammatory drugs cause several adverse events, with topical formulations arising as an important alternative. Therefore, we aimed at evaluating the efficacy and safety of loxoprofen patch (LX-P) in the treatment of patients with posttraumatic pain. This phase III, randomized, double-blind, noninferiority study enrolled Brazilian patients aged 18 to 65 years diagnosed with lower and upper limb posttraumatic injury who were experiencing moderate or severe pain. Patients were assigned to active LX-P or to loxoprofen tablet (LX-T), and pain intensity was measured based on a visual analog scale score variation after 7 days of treatment. Data on clinical symptoms, rescue medication use, and adverse events were also collected. Visual analog scale score variation was compared using a 10% noninferiority margin. Two hundred forty-two patients were randomly assigned to LX-P (n = 123) or to LX-T (n = 119). The results showed a reduction in pain after 7 days of treatment: -49.96 (n = 118; SE 1.7) in the LX-P and -47.71 (n = 117; SE 1.6) in the LX-T groups (difference of -2.25; 95% CI: -5.97 to 1.47; P = 0.23). On the safety analysis, the LX-T group presented twice as many patients with treatment-emergent adverse events as the LX-P group (30.8% and 14.2%, respectively). A sensitivity analysis demonstrated that rescue medication use has not affected the primary end point. This study showed that LX-P has a comparable efficacy to LX-T, but with a better safety profile, being a therapeutic option for the treatment of posttraumatic injury pain.

          Related collections

          Author and article information

          Journal
          Pain
          Pain
          Ovid Technologies (Wolters Kluwer Health)
          1872-6623
          0304-3959
          Jul 2019
          : 160
          : 7
          Affiliations
          [1 ] Faculdade de Medicina do ABC, Department Orthopaedics and Traumatology, Brazil.
          [2 ] Universidade Federal de São Paulo, EPFM-UNIFESP, Department of Orthopaedics and Traumatology, Brazil.
          [3 ] Universidade Federal da Bahia, UFBA, Department of Anesthesiology and Surgery, Brazil.
          [4 ] Universidade Federal de Goiás, UFG, Department of Orthopaedics and Traumatology, Brazil.
          [5 ] Hospital e MAternidade Cristóvão da Gama.
          [6 ] Daiichi Sankyo Brasil, Clinical Research Department, São Paulo, Brazil.
          Article
          00006396-201907000-00014
          10.1097/j.pain.0000000000001549
          30839430
          4c51bd71-9b0b-44c1-a22b-dcc7e3cd5bf1
          History

          Comments

          Comment on this article